Actively Recruiting
Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma
Led by University of Utah · Updated on 2025-11-28
40
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Historically, the frailest patients with multiple myeloma are under-represented in clinical trials, and have very high rates of treatment discontinuation, and early treatment mortality. The investigators hypothesize that a go-slow gentle approach to starting treatment in such patients, starting with just Isatuximab and dexamethasone with a gentle introduction to lenalidomide third cycle onwards, may improve treatment adherence and quality of life. The goal of this clinical trial is to learn if a go-slow approach to treating MM in ultra-frail patients may improve the ability to adhere to treatment and improve quality of life.
CONDITIONS
Official Title
Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Newly diagnosed with histologically confirmed multiple myeloma and/or plasma cell leukemia
- Completed no more than one prior cycle of myeloma treatment
- Female participants of childbearing potential must have a negative pregnancy test or be post-menopausal or surgically sterile
- Willing to follow contraception requirements and participate in the Lenalidomide REMS program
- Male participants agree to use a latex condom during intercourse for the study duration
- Recovery to baseline or Grade 1 or less from prior treatment toxicities unless stable and clinically nonsignificant
- Able to provide informed consent
- IMWG defined frailty score of 3 or higher
You will not qualify if you...
- Receiving other investigational agents
- Any condition that impairs ability to understand information, give consent, or safely participate (e.g., infection, inability to swallow medication, social or psychological issues)
- Severe hypersensitivity (Grade 3 or higher) to the investigational product or its components that cannot be managed with premedication
- Currently taking prohibited medications as described in the study protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
R
Rachel Kingsford
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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